Post-Sterilization Programming of Surgical Instruments

ABSTRACT

A surgical instrument with a programmable control unit and methods for programming the control unit while the surgical instrument is in a sterile container. The method may comprise packaging the surgical instrument in the container and then sterilizing the surgical instrument while the surgical instrument is in the container. The method may further comprise programming the surgical instrument while the surgical instrument is in the container with a programming device positioned outside of the container.

CROSS REFERENCE TO RELATED APPLICATIONS

The present continuation application claims benefit of U.S. patentapplication Ser. No. 11/651,771, filed on Jan. 10, 2007, which isincorporated herein by reference. The following applications are alsoincorporated by reference:

(1) U.S. patent application Ser. No. ______, entitled “SURGICALINSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSORTRANSPONDERS,” by J. Giordano et al. (Attorney Docket No.060338/END5923USNP);

(2) U.S. patent application Ser. No. ______, entitled “SURGICALINSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND REMOTESENSOR,” by J. Giordano et al. (Attorney Docket No. 060339/END5924USNP);

(3) U.S. patent application Ser. No. ______, entitled “SURGICALINSTRUMENT WITH ELEMENTS TO COMMUNICATE BETWEEN CONTROL UNIT AND ENDEFFECTOR,” by J. Giordano et al. (Attorney Docket No.060340/END5925USNP);

(4) U.S. patent application Ser. No. ______, entitled “PREVENTION OFCARTRIDGE REUSE IN A SURGICAL INSTRUMENT,” by F. Shelton et al.(Attorney Docket No. 060341/END5926USNP);

(5) U.S. patent application Ser. No. ______, entitled “INTERLOCK ANDSURGICAL INSTRUMENT INCLUDING SAME, by F. Shelton et al. (AttorneyDocket No. 060343/END5928USNP); and

(6) U.S. patent application Ser. No. ______, entitled “SURGICALINSTRUMENT WITH ENHANCED BATTERY PERFORMANCE,” by F. Shelton et al.(Attorney Docket No. 060347/END5931USNP).

BACKGROUND

Endoscopic surgical instruments are often preferred over traditionalopen surgical devices since a smaller incision tends to reduce thepost-operative recovery time and complications. Consequently,significant development has gone into a range of endoscopic surgicalinstruments that are suitable for precise placement of a distal endeffector at a desired surgical site through a cannula of a trocar. Thesedistal end effectors engage the tissue in a number of ways to achieve adiagnostic or therapeutic effect (e.g., endocutter, grasper, cutter,staplers, clip applier, access device, drug/gene therapy deliverydevice, and energy device using ultrasound, RF, laser, etc.).

Known surgical staplers include an end effector that simultaneouslymakes a longitudinal incision in tissue and applies lines of staples onopposing sides of the incision. The end effector includes a pair ofcooperating jaw members that, if the instrument is intended forendoscopic or laparoscopic applications, are capable of passing througha cannula passageway. One of the jaw members receives a staple cartridgehaving at least two laterally spaced rows of staples. The other jawmember defines an anvil having staple-forming pockets aligned with therows of staples in the cartridge. The instrument includes a plurality ofreciprocating wedges which, when driven distally, pass through openingsin the staple cartridge and engage drivers supporting the staples toeffect the firing of the staples toward the anvil.

An example of a surgical stapler suitable for endoscopic applications isdescribed in U.S. Pat. No. 5,465,895, which discloses an endocutter withdistinct closing and firing actions. A clinician using this device isable to close the jaw members upon tissue to position the tissue priorto firing. Once the clinician has determined that the jaw members areproperly gripping tissue, the clinician can then fire the surgicalstapler with a single firing stroke, thereby severing and stapling thetissue. The simultaneous severing and stapling avoids complications thatmay arise when performing such actions sequentially with differentsurgical tools that respectively only sever and staple.

One specific advantage of being able to close upon tissue before firingis that the clinician is able to verify via an endoscope that thedesired location for the cut has been achieved, including that asufficient amount of tissue has been captured between opposing jaws.Otherwise, opposing jaws may be drawn too close together, especiallypinching at their distal ends, and thus not effectively forming closedstaples in the severed tissue. At the other extreme, an excessive amountof clamped tissue may cause binding and an incomplete firing.

Endoscopic staplers/cutters continue to increase in complexity andfunction with each generation. One of the main reasons for this is thequest to lower force-to-fire (FTF) to a level that all or a greatmajority of surgeons can handle. One known solution to lower FTF it useCO₂ or electrical motors. These devices have not faired much better thantraditional hand-powered devices, but for a different reason. Surgeonstypically prefer to experience proportionate force distribution to thatbeing experienced by the end effector in the forming of the staple toassure them that the cutting/stapling cycle is complete, with the upperlimit within the capabilities of most surgeons (usually around 15-30lbs). They also typically want to maintain control of deploying thestaples and being able to stop at anytime if the forces felt in thehandle of the device feel too great or for some other clinical reason.

To address this need, so-called “power-assist” endoscopic surgicalinstruments have been developed in which a supplemental power sourceaids in the firing of the instrument. For example, in some power-assistdevices, a motor provides supplemental electrical power to the powerinput by the user from squeezing the firing trigger. Such devices arecapable of providing loading force feedback and control to the operatorto reduce the firing force required to be exerted by the operator inorder to complete the cutting operation. One such power-assist device isdescribed in U.S. patent application Ser. No. 11/343,573, filed Jan. 31,2006 by Shelton et al., entitled “Motor-driven surgical cutting andfastening instrument with loading force feedback,” (“the '573application”) which is incorporated herein by reference.

These power-assist devices often include other components that purelymechanical endoscopic surgical instruments do not, such as sensors andcontrol systems. One challenge in using such electronics in a surgicalinstrument is delivering power and/or data to and from the sensors,particularly when there is a free rotating joint in the surgicalinstrument.

SUMMARY

In one general aspect, the present invention is directed to a surgicalinstrument, such as an endoscopic or laparoscopic instrument. Accordingto one embodiment, the surgical instrument comprises an end effectorcomprising at least one sensor transponder that is passively powered.The surgical instrument also comprises a shaft having a distal endconnected to the end effector and a handle connected to a proximate endof the shaft. The handle comprises a control unit (e.g., amicrocontroller) that is in communication with the sensor transpondervia at least one inductive coupling. Further, the surgical instrumentmay comprise a rotational joint for rotating the shaft. In such a case,the surgical instrument may comprise a first inductive element locatedin the shaft distally from the rotational joint and inductively coupledto the control unit, and a second inductive element located distally inthe shaft and inductively coupled to the at least one sensortransponder. The first and second inductive elements may be connected bya wired, physical connection.

That way, the control unit may communicate with the transponder in theend effector without a direct wired connection through complexmechanical joints like the rotating joint where it may be difficult tomaintain such a wired connection. In addition, because the distancesbetween the inductive elements may be fixed and known, the couplingscould be optimized for inductive transfer of energy. Also, the distancescould be relatively short so that relatively low power signals could beused to thereby minimize interference with other systems in the useenvironment of the instrument.

In another general aspect of the present invention, the electricallyconductive shaft of the surgical instrument may serve as an antenna forthe control unit to wirelessly communicate signals to and from thesensor transponder. For example, the sensor transponder could be locatedon or disposed in a nonconductive component of the end effector, such asa plastic cartridge, thereby insulating the sensor from conductivecomponents of the end effector and the shaft. In addition, the controlunit in the handle may be electrically coupled to the shaft. In thatway, the shaft and/or the end effector may serve as an antenna for thecontrol unit by radiating signals from the control unit to the sensorand/or by receiving radiated signals from the sensor. Such a design isparticularly useful in surgical instruments having complex mechanicaljoints (such as rotary joints), which make it difficult to use a directwired connection between the sensor and control unit for communicatingdata signals.

In another embodiment, the shaft and/or components of the end effectorcould serve as the antenna for the sensor by radiating signals to thecontrol unit and receiving radiated signals from the control unit.According to such an embodiment, the control unit is electricallyinsulated from the shaft and the end effector.

In another general aspect, the present invention is directed to asurgical instrument comprising a programmable control unit that can beprogrammed by a programming device after the instrument has beenpackaged and sterilized. In one such embodiment, the programming devicemay wirelessly program the control unit. The control unit may bepassively powered by the wireless signals from the programming deviceduring the programming operation. In another embodiment, the sterilecontainer may comprise a connection interface so that the programmingunit can be connected to the surgical instrument while the surgicalinstrument is in its sterilized container.

FIGURES

Various embodiments of the present invention are described herein by wayof example in conjunction with the following figures wherein:

FIGS. 1 and 2 are perspective views of a surgical instrument accordingto various embodiments of the present invention;

FIGS. 3-5 are exploded views of an end effector and shaft of theinstrument according to various embodiments of the present invention;

FIG. 6 is a side view of the end effector according to variousembodiments of the present invention;

FIG. 7 is an exploded view of the handle of the instrument according tovarious embodiments of the present invention;

FIGS. 8 and 9 are partial perspective views of the handle according tovarious embodiments of the present invention;

FIG. 10 is a side view of the handle according to various embodiments ofthe present invention;

FIGS. 11, 13-14, 16, and 22 are perspective views of a surgicalinstrument according to various embodiments of the present invention;

FIGS. 12 and 19 are block diagrams of a control unit according tovarious embodiments of the present invention;

FIG. 15 is a side view of an end effector including a sensor transponderaccording to various embodiments of the present invention;

FIGS. 17 and 18 show the instrument in a sterile container according tovarious embodiments of the present invention;

FIG. 20 is a block diagram of the remote programming device according tovarious embodiments of the present invention; and

FIG. 21 is a diagram of a packaged instrument according to variousembodiments of the present invention.

DETAILED DESCRIPTION

Various embodiments of the present invention are directed generally to asurgical instrument having at least one remote sensor transponder andmeans for communicating power and/or data signals to the transponder(s)from a control unit. The present invention may be used with any type ofsurgical instrument comprising at least one sensor transponder, such asendoscopic or laparoscopic surgical instruments, but is particularlyuseful for surgical instruments where some feature of the instrument,such as a free rotating joint, prevents or otherwise inhibits the use ofa wired connection to the sensor(s). Before describing aspects of thesystem, one type of surgical instrument in which embodiments of thepresent invention may be used—an endoscopic stapling and cuttinginstrument (i.e., an endocutter)—is first described by way ofillustration.

FIGS. 1 and 2 depict an endoscopic surgical instrument 10 that comprisesa handle 6, a shaft 8, and an articulating end effector 12 pivotallyconnected to the shaft 8 at an articulation pivot 14. Correct placementand orientation of the end effector 12 may be facilitated by controls onthe hand 6, including (1) a rotation knob 28 for rotating the closuretube (described in more detail below in connection with FIGS. 4-5) at afree rotating joint 29 of the shaft 8 to thereby rotate the end effector12 and (2) an articulation control 16 to effect rotational articulationof the end effector 12 about the articulation pivot 14. In theillustrated embodiment, the end effector 12 is configured to act as anendocutter for clamping, severing and stapling tissue, although in otherembodiments, different types of end effectors may be used, such as endeffectors for other types of surgical instruments, such as graspers,cutters, staplers, clip appliers, access devices, drug/gene therapydevices, ultrasound, RF or laser devices, etc.

The handle 6 of the instrument 10 may include a closure trigger 18 and afiring trigger 20 for actuating the end effector 12. It will beappreciated that instruments having end effectors directed to differentsurgical tasks may have different numbers or types of triggers or othersuitable controls for operating the end effector 12. The end effector 12is shown separated from the handle 6 by the preferably elongate shaft 8.In one embodiment, a clinician or operator of the instrument 10 mayarticulate the end effector 12 relative to the shaft 8 by utilizing thearticulation control 16, as described in more detail in pending U.S.patent application Ser. No. 11/329,020, filed Jan. 10, 2006, entitled“Surgical Instrument Having An Articulating End Effector,” by GeoffreyC. Hueil et al., which is incorporated herein by reference.

The end effector 12 includes in this example, among other things, astaple channel 22 and a pivotally translatable clamping member, such asan anvil 24, which are maintained at a spacing that assures effectivestapling and severing of tissue clamped in the end effector 12. Thehandle 6 includes a pistol grip 26 towards which a closure trigger 18 ispivotally drawn by the clinician to cause clamping or closing of theanvil 24 toward the staple channel 22 of the end effector 12 to therebyclamp tissue positioned between the anvil 24 and channel 22. The firingtrigger 20 is farther outboard of the closure trigger 18. Once theclosure trigger 18 is locked in the closure position, the firing trigger20 may rotate slightly toward the pistol grip 26 so that it can bereached by the operator using one hand. Then the operator may pivotallydraw the firing trigger 20 toward the pistol grip 12 to cause thestapling and severing of clamped tissue in the end effector 12. The '573application describes various configurations for locking and unlockingthe closure trigger 18. In other embodiments, different types ofclamping members besides the anvil 24 could be used, such as, forexample, an opposing jaw, etc.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping the handle 6 of aninstrument 10. Thus, the end effector 12 is distal with respect to themore proximal handle 6. It will be further appreciated that, forconvenience and clarity, spatial terms such as “vertical” and“horizontal” are used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and absolute.

The closure trigger 18 may be actuated first. Once the clinician issatisfied with the positioning of the end effector 12, the clinician maydraw back the closure trigger 18 to its fully closed, locked positionproximate to the pistol grip 26. The firing trigger 20 may then beactuated. The firing trigger 20 returns to the open position (shown inFIGS. 1 and 2) when the clinician removes pressure. A release button 30on the handle 6, and in this example, on the pistol grip 26 of thehandle, when depressed may release the locked closure trigger 18.

FIG. 3 is an exploded view of the end effector 12 according to variousembodiments. As shown in the illustrated embodiment, the end effector 12may include, in addition to the previously-mentioned channel 22 andanvil 24, a cutting instrument 32, a sled 33, a staple cartridge 34 thatis removably seated in the channel 22, and a helical screw shaft 36. Thecutting instrument 32 may be, for example, a knife. The anvil 24 may bepivotably opened and closed at a pivot point 25 connected to theproximate end of the channel 22. The anvil 24 may also include a tab 27at its proximate end that is inserted into a component of the mechanicalclosure system (described further below) to open and close the anvil 24.When the closure trigger 18 is actuated, that is, drawn in by a user ofthe instrument 10, the anvil 24 may pivot about the pivot point 25 intothe clamped or closed position. If clamping of the end effector 12 issatisfactory, the operator may actuate the firing trigger 20, which, asexplained in more detail below, causes the knife 32 and sled 33 totravel longitudinally along the channel 22, thereby cutting tissueclamped within the end effector 12. The movement of the sled 33 alongthe channel 22 causes the staples of the staple cartridge 34 to bedriven through the severed tissue and against the closed anvil 24, whichturns the staples to fasten the severed tissue. U.S. Pat. No. 6,978,921,entitled “Surgical stapling instrument incorporating an E-beam firingmechanism,” which is incorporated herein by reference, provides moredetails about such two-stroke cutting and fastening instruments. Thesled 33 may be part of the cartridge 34, such that when the knife 32retracts following the cutting operation, the sled 33 does not retract.The channel 22 and the anvil 24 may be made of an electricallyconductive material (such as metal) so that they may serve as part ofthe antenna that communicates with the sensor(s) in the end effector, asdescribed further below. The cartridge 34 could be made of anonconductive material (such as plastic) and the sensor may be connectedto or disposed in the cartridge 34, as described further below.

It should be noted that although the embodiments of the instrument 10described herein employ an end effector 12 that staples the severedtissue, in other embodiments different techniques for fastening orsealing the severed tissue may be used. For example, end effectors thatuse RF energy or adhesives to fasten the severed tissue may also beused. U.S. Pat. No. 5,709,680, entitled “Electrosurgical HemostaticDevice” to Yates et al., and U.S. Pat. No. 5,688,270, entitled“Electrosurgical Hemostatic Device With Recessed And/Or OffsetElectrodes” to Yates et al., which are incorporated herein by reference,discloses cutting instruments that use RF energy to fasten the severedtissue. U.S. patent application Ser. No. 11/267,811 to Morgan et al. andU.S. patent application Ser. No. 11/267,363 to Shelton et al., which arealso incorporated herein by reference, disclose cutting instruments thatuse adhesives to fasten the severed tissue. Accordingly, although thedescription herein refers to cutting/stapling operations and the like,it should be recognized that this is an exemplary embodiment and is notmeant to be limiting. Other tissue-fastening techniques may also beused.

FIGS. 4 and 5 are exploded views and FIG. 6 is a side view of the endeffector 12 and shaft 8 according to various embodiments. As shown inthe illustrated embodiment, the shaft 8 may include a proximate closuretube 40 and a distal closure tube 42 pivotably linked by a pivot links44. The distal closure tube 42 includes an opening 45 into which the tab27 on the anvil 24 is inserted in order to open and close the anvil 24.Disposed inside the closure tubes 40, 42 may be a proximate spine tube46. Disposed inside the proximate spine tube 46 may be a main rotational(or proximate) drive shaft 48 that communicates with a secondary (ordistal) drive shaft 50 via a bevel gear assembly 52. The secondary driveshaft 50 is connected to a drive gear 54 that engages a proximate drivegear 56 of the helical screw shaft 36. The vertical bevel gear 52 b maysit and pivot in an opening 57 in the distal end of the proximate spinetube 46. A distal spine tube 58 may be used to enclose the secondarydrive shaft 50 and the drive gears 54, 56. Collectively, the main driveshaft 48, the secondary drive shaft 50, and the articulation assembly(e.g., the bevel gear assembly 52 a-c), are sometimes referred to hereinas the “main drive shaft assembly.” The closure tubes 40, 42 may be madeof electrically conductive material (such as metal) so that they mayserve as part of the antenna, as described further below. Components ofthe main drive shaft assembly (e.g., the drive shafts 48, 50) may bemade of a nonconductive material (such as plastic).

A bearing 38, positioned at a distal end of the staple channel 22,receives the helical drive screw 36, allowing the helical drive screw 36to freely rotate with respect to the channel 22. The helical screw shaft36 may interface a threaded opening (not shown) of the knife 32 suchthat rotation of the shaft 36 causes the knife 32 to translate distallyor proximately (depending on the direction of the rotation) through thestaple channel 22. Accordingly, when the main drive shaft 48 is causedto rotate by actuation of the firing trigger 20 (as explained in moredetail below), the bevel gear assembly 52 a-c causes the secondary driveshaft 50 to rotate, which in turn, because of the engagement of thedrive gears 54, 56, causes the helical screw shaft 36 to rotate, whichcauses the knife 32 to travel longitudinally along the channel 22 to cutany tissue clamped within the end effector. The sled 33 may be made of,for example, plastic, and may have a sloped distal surface. As the sled33 traverses the channel 22, the sloped forward surface may push up ordrive the staples in the staple cartridge 34 through the clamped tissueand against the anvil 24. The anvil 24 turns the staples, therebystapling the severed tissue. When the knife 32 is retracted, the knife32 and sled 33 may become disengaged, thereby leaving the sled 33 at thedistal end of the channel 22.

According to various embodiments, as shown FIGS. 7-10, the surgicalinstrument may include a battery 64 in the handle 6. The illustratedembodiment provides user-feedback regarding the deployment and loadingforce of the cutting instrument in the end effector 12. In addition, theembodiment may use power provided by the user in retracting the firingtrigger 18 to power the instrument 10 (a so-called “power assist” mode).As shown in the illustrated embodiment, the handle 6 includes exteriorlower side pieces 59, 60 and exterior upper side pieces 61, 62 that fittogether to form, in general, the exterior of the handle 6. The handlepieces 59-62 may be made of an electrically nonconductive material, suchas plastic. A battery 64 may be provided in the pistol grip portion 26of the handle 6. The battery 64 powers a motor 65 disposed in an upperportion of the pistol grip portion 26 of the handle 6. The battery 64may be constructed according to any suitable construction or chemistryincluding, for example, a Li-ion chemistry such as LiCoO₂ or LiNiO₂, aNickel Metal Hydride chemistry, etc. According to various embodiments,the motor 65 may be a DC brushed driving motor having a maximum rotationof, approximately, 5000 RPM to 100,000 RPM. The motor 64 may drive a 90°bevel gear assembly 66 comprising a first bevel gear 68 and a secondbevel gear 70. The bevel gear assembly 66 may drive a planetary gearassembly 72. The planetary gear assembly 72 may include a pinion gear 74connected to a drive shaft 76. The pinion gear 74 may drive a matingring gear 78 that drives a helical gear drum 80 via a drive shaft 82. Aring 84 may be threaded on the helical gear drum 80. Thus, when themotor 65 rotates, the ring 84 is caused to travel along the helical geardrum 80 by means of the interposed bevel gear assembly 66, planetarygear assembly 72 and ring gear 78.

The handle 6 may also include a run motor sensor 110 in communicationwith the firing trigger 20 to detect when the firing trigger 20 has beendrawn in (or “closed”) toward the pistol grip portion 26 of the handle 6by the operator to thereby actuate the cutting/stapling operation by theend effector 12. The sensor 110 may be a proportional sensor such as,for example, a rheostat or variable resistor. When the firing trigger 20is drawn in, the sensor 110 detects the movement, and sends anelectrical signal indicative of the voltage (or power) to be supplied tothe motor 65. When the sensor 110 is a variable resistor or the like,the rotation of the motor 65 may be generally proportional to the amountof movement of the firing trigger 20. That is, if the operator onlydraws or closes the firing trigger 20 in a little bit, the rotation ofthe motor 65 is relatively low. When the firing trigger 20 is fullydrawn in (or in the fully closed position), the rotation of the motor 65is at its maximum. In other words, the harder the user pulls on thefiring trigger 20, the more voltage is applied to the motor 65, causinggreater rates of rotation. In another embodiment, for example, thecontrol unit (described further below) may output a PWM control signalto the motor 65 based on the input from the sensor 110 in order tocontrol the motor 65.

The handle 6 may include a middle handle piece 104 adjacent to the upperportion of the firing trigger 20. The handle 6 also may comprise a biasspring 112 connected between posts on the middle handle piece 104 andthe firing trigger 20. The bias spring 112 may bias the firing trigger20 to its fully open position. In that way, when the operator releasesthe firing trigger 20, the bias spring 112 will pull the firing trigger20 to its open position, thereby removing actuation of the sensor 110,thereby stopping rotation of the motor 65. Moreover, by virtue of thebias spring 112, any time a user closes the firing trigger 20, the userwill experience resistance to the closing operation, thereby providingthe user with feedback as to the amount of rotation exerted by the motor65. Further, the operator could stop retracting the firing trigger 20 tothereby remove force from the sensor 100, to thereby stop the motor 65.As such, the user may stop the deployment of the end effector 12,thereby providing a measure of control of the cutting/fasteningoperation to the operator.

The distal end of the helical gear drum 80 includes a distal drive shaft120 that drives a ring gear 122, which mates with a pinion gear 124. Thepinion gear 124 is connected to the main drive shaft 48 of the maindrive shaft assembly. In that way, rotation of the motor 65 causes themain drive shaft assembly to rotate, which causes actuation of the endeffector 12, as described above.

The ring 84 threaded on the helical gear drum 80 may include a post 86that is disposed within a slot 88 of a slotted arm 90. The slotted arm90 has an opening 92 at its opposite end 94 that receives a pivot pin 96that is connected between the handle exterior side pieces 59, 60. Thepivot pin 96 is also disposed through an opening 100 in the firingtrigger 20 and an opening 102 in the middle handle piece 104.

In addition, the handle 6 may include a reverse motor (or end-of-strokesensor) 130 and a stop motor (or beginning-of-stroke) sensor 142. Invarious embodiments, the reverse motor sensor 130 may be a limit switchlocated at the distal end of the helical gear drum 80 such that the ring84 threaded on the helical gear drum 80 contacts and trips the reversemotor sensor 130 when the ring 84 reaches the distal end of the helicalgear drum 80. The reverse motor sensor 130, when activated, sends asignal to the control unit which sends a signal to the motor 65 toreverse its rotation direction, thereby withdrawing the knife 32 of theend effector 12 following the cutting operation.

The stop motor sensor 142 may be, for example, a normally-closed limitswitch. In various embodiments, it may be located at the proximate endof the helical gear drum 80 so that the ring 84 trips the switch 142when the ring 84 reaches the proximate end of the helical gear drum 80.

In operation, when an operator of the instrument 10 pulls back thefiring trigger 20, the sensor 110 detects the deployment of the firingtrigger 20 and sends a signal to the control unit which sends a signalto the motor 65 to cause forward rotation of the motor 65 at, forexample, a rate proportional to how hard the operator pulls back thefiring trigger 20. The forward rotation of the motor 65 in turn causesthe ring gear 78 at the distal end of the planetary gear assembly 72 torotate, thereby causing the helical gear drum 80 to rotate, causing thering 84 threaded on the helical gear drum 80 to travel distally alongthe helical gear drum 80. The rotation of the helical gear drum 80 alsodrives the main drive shaft assembly as described above, which in turncauses deployment of the knife 32 in the end effector 12. That is, theknife 32 and sled 33 are caused to traverse the channel 22longitudinally, thereby cutting tissue clamped in the end effector 12.Also, the stapling operation of the end effector 12 is caused to happenin embodiments where a stapling-type end effector is used.

By the time the cutting/stapling operation of the end effector 12 iscomplete, the ring 84 on the helical gear drum 80 will have reached thedistal end of the helical gear drum 80, thereby causing the reversemotor sensor 130 to be tripped, which sends a signal to the control unitwhich sends a signal to the motor 65 to cause the motor 65 to reverseits rotation. This in turn causes the knife 32 to retract, and alsocauses the ring 84 on the helical gear drum 80 to move back to theproximate end of the helical gear drum 80.

The middle handle piece 104 includes a backside shoulder 106 thatengages the slotted arm 90 as best shown in FIGS. 8 and 9. The middlehandle piece 104 also has a forward motion stop 107 that engages thefiring trigger 20. The movement of the slotted arm 90 is controlled, asexplained above, by rotation of the motor 65. When the slotted arm 90rotates CCW as the ring 84 travels from the proximate end of the helicalgear drum 80 to the distal end, the middle handle piece 104 will be freeto rotate CCW. Thus, as the user draws in the firing trigger 20, thefiring trigger 20 will engage the forward motion stop 107 of the middlehandle piece 104, causing the middle handle piece 104 to rotate CCW. Dueto the backside shoulder 106 engaging the slotted arm 90, however, themiddle handle piece 104 will only be able to rotate CCW as far as theslotted arm 90 permits. In that way, if the motor 65 should stoprotating for some reason, the slotted arm 90 will stop rotating, and theuser will not be able to further draw in the firing trigger 20 becausethe middle handle piece 104 will not be free to rotate CCW due to theslotted arm 90.

Components of an exemplary closure system for closing (or clamping) theanvil 24 of the end effector 12 by retracting the closure trigger 18 arealso shown in FIGS. 7-10. In the illustrated embodiment, the closuresystem includes a yoke 250 connected to the closure trigger 18 by a pin251 that is inserted through aligned openings in both the closuretrigger 18 and the yoke 250. A pivot pin 252, about which the closuretrigger 18 pivots, is inserted through another opening in the closuretrigger 18 which is offset from where the pin 251 is inserted throughthe closure trigger 18. Thus, retraction of the closure trigger 18causes the upper part of the closure trigger 18, to which the yoke 250is attached via the pin 251, to rotate CCW. The distal end of the yoke250 is connected, via a pin 254, to a first closure bracket 256. Thefirst closure bracket 256 connects to a second closure bracket 258.Collectively, the closure brackets 256, 258 define an opening in whichthe proximate end of the proximate closure tube 40 (see FIG. 4) isseated and held such that longitudinal movement of the closure brackets256, 258 causes longitudinal motion by the proximate closure tube 40.The instrument 10 also includes a closure rod 260 disposed inside theproximate closure tube 40. The closure rod 260 may include a window 261into which a post 263 on one of the handle exterior pieces, such asexterior lower side piece 59 in the illustrated embodiment, is disposedto fixedly connect the closure rod 260 to the handle 6. In that way, theproximate closure tube 40 is capable of moving longitudinally relativeto the closure rod 260. The closure rod 260 may also include a distalcollar 267 that fits into a cavity 269 in proximate spine tube 46 and isretained therein by a cap 271 (see FIG. 4).

In operation, when the yoke 250 rotates due to retraction of the closuretrigger 18, the closure brackets 256, 258 cause the proximate closuretube 40 to move distally (i.e., away from the handle end of theinstrument 10), which causes the distal closure tube 42 to movedistally, which causes the anvil 24 to rotate about the pivot point 25into the clamped or closed position. When the closure trigger 18 isunlocked from the locked position, the proximate closure tube 40 iscaused to slide proximately, which causes the distal closure tube 42 toslide proximately, which, by virtue of the tab 27 being inserted in thewindow 45 of the distal closure tube 42, causes the anvil 24 to pivotabout the pivot point 25 into the open or unclamped position. In thatway, by retracting and locking the closure trigger 18, an operator mayclamp tissue between the anvil 24 and channel 22, and may unclamp thetissue following the cutting/stapling operation by unlocking the closuretrigger 18 from the locked position.

The control unit (described further below) may receive the outputs fromend-of-stroke and beginning-of-stroke sensors 130, 142 and the run-motorsensor 110, and may control the motor 65 based on the inputs. Forexample, when an operator initially pulls the firing trigger 20 afterlocking the closure trigger 18, the run-motor sensor 110 is actuated. Ifthe staple cartridge 34 is present in the end effector 12, a cartridgelockout sensor (not shown) may be closed, in which case the control unitmay output a control signal to the motor 65 to cause the motor 65 torotate in the forward direction. When the end effector 12 reaches theend of its stroke, the reverse motor sensor 130 will be activated. Thecontrol unit may receive this output from the reverse motor sensor 130and cause the motor 65 to reverse its rotational direction. When theknife 32 is fully retracted, the stop motor sensor switch 142 isactivated, causing the control unit to stop the motor 65.

In other embodiments, rather than a proportional-type sensor 110, anon-off type sensor could be used. In such embodiments, the rate ofrotation of the motor 65 would not be proportional to the force appliedby the operator. Rather, the motor 65 would generally rotate at aconstant rate. But the operator would still experience force feedbackbecause the firing trigger 20 is geared into the gear drive train.

The instrument 10 may include a number of sensor transponders in the endeffector 12 for sensing various conditions related to the end effector12, such as sensor transponders for determining the status of the staplecartridge 34 (or other type of cartridge depending on the type ofsurgical instrument), the progress of the stapler during closure andfiring, etc. The sensor transponders may be passively powered byinductive signals, as described further below, although in otherembodiments the transponders could be powered by a remote power source,such as a battery in the end effector 12, for example. The sensortransponder(s) could include magnetoresistive, optical,electromechanical, RFID, MEMS, motion or pressure sensors, for example.These sensor transponders may be in communication with a control unit300, which may be housed in the handle 6 of the instrument 10, forexample, as shown in FIG. 11.

As shown in FIG. 12, according to various embodiments the control unit300 may comprise a processor 306 and one or more memory units 308. Byexecuting instruction code stored in the memory 308, the processor 306may control various components of the instrument 10, such as the motor65 or a user display (not shown), based on inputs received from thevarious end effector sensor transponders and other sensor(s) (such asthe run-motor sensor 110, the end-of-stroke sensor 130, and thebeginning-of-stroke sensor 142, for example). The control unit 300 maybe powered by the battery 64 during surgical use of instrument 10. Thecontrol unit 300 may comprise an inductive element 302 (e.g., a coil orantenna) to pick up wireless signals from the sensor transponders, asdescribed in more detail below. Input signals received by the inductiveelement 302 acting as a receiving antenna may be demodulated by ademodulator 310 and decoded by a decoder 312. The input signals maycomprise data from the sensor transponders in the end effector 12, whichthe processor 306 may use to control various aspects of the instrument10.

To transmit signals to the sensor transponders, the control unit 300 maycomprise an encoder 316 for encoding the signals and a modulator 318 formodulating the signals according to the modulation scheme. The inductiveelement 302 may act as the transmitting antenna. The control unit 300may communicate with the sensor transponders using any suitable wirelesscommunication protocol and any suitable frequency (e.g., an ISM band).Also, the control unit 300 may transmit signals at a different frequencyrange than the frequency range of the received signals from the sensortransponders. Also, although only one antenna (inductive element 302) isshown in FIG. 12, in other embodiments the control unit 300 may haveseparate receiving and transmitting antennas.

According to various embodiments, the control unit 300 may comprise amicrocontroller, a microprocessor, a field programmable gate array(FPGA), one or more other types of integrated circuits (e.g., RFreceivers and PWM controllers), and/or discrete passive components. Thecontrol units may also be embodied as system-on-chip (SoC) or asystem-in-package (SIP), for example.

As shown in FIG. 11, the control unit 300 may be housed in the handle 6of the instrument 10 and one or more of the sensor transponders 368 forthe instrument 10 may be located in the end effector 12. To deliverpower and/or transmit data to or from the sensor transponders 368 in theend effector 12, the inductive element 302 of the control unit 300 maybe inductively coupled to a secondary inductive element (e.g., a coil)320 positioned in the shaft 8 distally from the rotation joint 29. Thesecondary inductive element 320 is preferably electrically insulatedfrom the conductive shaft 8.

The secondary inductive element 320 may be connected by an electricallyconductive, insulated wire 322 to a distal inductive element (e.g., acoil) 324 located near the end effector 12, and preferably distallyrelative to the articulation pivot 14. The wire 322 may be made of anelectrically conductive polymer and/or metal (e.g., copper) and may besufficiently flexible so that it could pass though the articulationpivot 14 and not be damaged by articulation. The distal inductiveelement 324 may be inductively coupled to the sensor transponder 368 in,for example, the cartridge 34 of the end effector 12. The transponder368, as described in more detail below, may include an antenna (or coil)for inductive coupling to the distal coil 324, a sensor and integratedcontrol electronics for receiving and transmitting wirelesscommunication signals.

The transponder 368 may use a portion of the power of the inductivesignal received from the distal inductive element 326 to passively powerthe transponder 368. Once sufficiently powered by the inductive signals,the transponder 368 may receive and transmit data to the control unit300 in the handle 6 via (i) the inductive coupling between thetransponder 368 and the distal inductive element 324, (ii) the wire 322,and (iii) the inductive coupling between the secondary inductive element320 and the control unit 300. That way, the control unit 300 maycommunicate with the transponder 368 in the end effector 12 without adirect wired connection through complex mechanical joints like therotating joint 29 and/or without a direct wired connection from theshaft 8 to the end effector 12, places where it may be difficult tomaintain such a wired connection. In addition, because the distancesbetween the inductive elements (e.g., the spacing between (i) thetransponder 368 and the distal inductive element 324, and (ii) thesecondary inductive element 320 and the control unit 300) and fixed andknown, the couplings could be optimized for inductive transfer ofenergy. Also, the distances could be relatively short so that relativelylow power signals could be used to thereby minimize interference withother systems in the use environment of the instrument 10.

In the embodiment of FIG. 12, the inductive element 302 of the controlunit 300 is located relatively near to the control unit 300. Accordingto other embodiments, as shown in FIG. 13, the inductive element 302 ofthe control unit 300 may be positioned closer to the rotating joint 29to that it is closer to the secondary inductive element 320, therebyreducing the distance of the inductive coupling in such an embodiment.Alternatively, the control unit 300 (and hence the inductive element302) could be positioned closer to the secondary inductive element 320to reduce the spacing.

In other embodiments, more or fewer than two inductive couplings may beused. For example, in some embodiments, the surgical instrument 10 mayuse a single inductive coupling between the control unit 300 in thehandle 6 and the transponder 368 in the end effector 12, therebyeliminating the inductive elements 320, 324 and the wire 322. Of course,in such an embodiment, a stronger signal may be required due to thegreater distance between the control unit 300 in the handle 6 and thetransponder 368 in the end effector 12. Also, more than two inductivecouplings could be used. For example, if the surgical instrument 10 hadnumerous complex mechanical joints where it would be difficult tomaintain a direct wired connection, inductive couplings could be used tospan each such joint. For example, inductive couplers could be used onboth sides of the rotary joint 29 and both sides of the articulationpivot 14, with the inductive element 321 on the distal side of therotary joint 29 connected by a wire 322 to the inductive element 324 ofthe proximate side of the articulation pivot, and a wire 323 connectingthe inductive elements 325, 326 on the distal side of the articulationpivot 14 as shown in FIG. 14. In this embodiment, the inductive element326 may communicate with the sensor transponder 368.

In addition, the transponder 368 may include a number of differentsensors. For example, it may include an array of sensors. Further, theend effector 12 could include a number of sensor transponders 368 incommunication with the distal inductive element 324 (and hence thecontrol unit 300). Also, the inductive elements 320, 324 may or may notinclude ferrite cores. As mentioned before, they are also preferablyinsulated from the electrically conductive outer shaft (or frame) of theinstrument 10 (e.g., the closure tubes 40, 42), and the wire 322 is alsopreferably insulated from the outer shaft 8.

FIG. 15 is a diagram of an end effector 12 including a transponder 368held or embedded in the cartridge 34 at the distal end of the channel22. The transponder 368 may be connected to the cartridge 34 by asuitable bonding material, such as epoxy. In this embodiment, thetransponder 368 includes a magnetoresistive sensor. The anvil 24 alsoincludes a permanent magnet 369 at its distal end and generally facingthe transponder 368. The end effector 12 also includes a permanentmagnet 370 connected to the sled 33 in this example embodiment. Thisallows the transponder 368 to detect both opening/closing of the endeffector 12 (due to the permanent magnet 369 moving further or closer tothe transponder as the anvil 24 opens and closes) and completion of thestapling/cutting operation (due to the permanent magnet 370 movingtoward the transponder 368 as the sled 33 traverses the channel 22 aspart of the cutting operation).

FIG. 15 also shows the staples 380 and the staple drivers 382 of thestaple cartridge 34. As explained previously, according to variousembodiments, when the sled 33 traverses the channel 22, the sled 33drives the staple drivers 382 which drive the staples 380 into thesevered tissue held in the end effector 12, the staples 380 being formedagainst the anvil 24. As noted above, such a surgical cutting andfastening instrument is but one type of surgical instrument in which thepresent invention may be advantageously employed. Various embodiments ofthe present invention may be used in any type of surgical instrumenthaving one or more sensor transponders.

In the embodiments described above, the battery 64 powers (at leastpartially) the firing operation of the instrument 10. As such, theinstrument may be a so-called “power-assist” device. More details andadditional embodiments of power-assist devices are described in the '573application, which is incorporated herein. It should be recognized,however, that the instrument 10 need not be a power-assist device andthat this is merely an example of a type of device that may utilizeaspects of the present invention. For example, the instrument 10 mayinclude a user display (such as a LCD or LED display) that is powered bythe battery 64 and controlled by the control unit 300. Data from thesensor transponders 368 in the end effector 12 may be displayed on sucha display.

In another embodiment, the shaft 8 of the instrument 10, including forexample, the proximate closure tube 40 and the distal closure tube 42,may collectively serve as part of an antenna for the control unit 300 byradiating signals to the sensor transponder 368 and receiving radiatedsignals from the sensor transponder 368. That way, signals to and fromthe remote sensor in the end effector 12 may be transmitted via theshaft 8 of the instrument 10.

The proximate closure tube 40 may be grounded at its proximate end bythe exterior lower and upper side pieces 59-62, which may be made of anonelectrically conductive material, such as plastic. The drive shaftassembly components (including the main drive shaft 48 and secondarydrive shaft 50) inside the proximate and distal closure tubes 40, 42 mayalso be made of a nonelectrically conductive material, such as plastic.Further, components of end effector 12 (such as the anvil 24 and thechannel 22) may be electrically coupled to (or in direct or indirectelectrical contact with) the distal closure tube 42 such that they mayalso serve as part of the antenna. Further, the sensor transponder 368could be positioned such that it is electrically insulated from thecomponents of the shaft 8 and end effector 12 serving as the antenna.For example, the sensor transponder 368 may be positioned in thecartridge 34, which may be made of a nonelectrically conductivematerial, such as plastic. Because the distal end of the shaft 8 (suchas the distal end of the distal closure tube 42) and the portions of theend effector 12 serving as the antenna may be relatively close indistance to the sensor 368, the power for the transmitted signals may beheld at low levels, thereby minimizing or reducing interference withother systems in the use environment of the instrument 10.

In such an embodiment, as shown in FIG. 16, the control unit 300 may beelectrically coupled to the shaft 8 of the instrument 10, such as to theproximate closure tube 40, by a conductive link 400 (e.g., a wire).Portions of the outer shaft 8, such as the closure tubes 40, 42, maytherefore act as part of an antenna for the control unit 300 byradiating signals to the sensor 368 and receiving radiated signals fromthe sensor 368. Input signals received by the control unit 300 may bedemodulated by the demodulator 310 and decoded by the decoder 312 (seeFIG. 12). The input signals may comprise data from the sensors 368 inthe end effector 12, which the processor 306 may use to control variousaspects of the instrument 10, such as the motor 65 or a user display.

To transmit data signals to or from the sensors 368 in the end effector12, the link 400 may connect the control unit 300 to components of theshaft 8 of the instrument 10, such as the proximate closure tube 40,which may be electrically connected to the distal closure tube 42. Thedistal closure tube 42 is preferably electrically insulated from theremote sensor 368, which may be positioned in the plastic cartridge 34(see FIG. 3). As mentioned before, components of the end effector 12,such as the channel 22 and the anvil 24 (see FIG. 3), may be conductiveand in electrical contact with the distal closure tube 42 such thatthey, too, may serve as part of the antenna.

With the shaft 8 acting as the antenna for the control unit 300, thecontrol unit 300 can communicate with the sensor 368 in the end effector12 without a direct wired connection. In addition, because the distancesbetween shaft 8 and the remote sensor 368 is fixed and known, the powerlevels could be optimized for low levels to thereby minimizeinterference with other systems in the use environment of the instrument10. The sensor 368 may include communication circuitry for radiatingsignals to the control unit 300 and for receiving signals from thecontrol unit 300, as described above. The communication circuitry may beintegrated with the sensor 368.

In another embodiment, the components of the shaft 8 and/or the endeffector 12 may serve as an antenna for the remote sensor 368. In suchan embodiment, the remote sensor 368 is electrically connected to theshaft (such as to distal closure tube 42, which may be electricallyconnected to the proximate closure tube 40) and the control unit 300 isinsulated from the shaft 8. For example, the sensor 368 could beconnected to a conductive component of the end effector 12 (such as thechannel 22), which in turn may be connected to conductive components ofthe shaft (e.g., the closure tubes 40, 42). Alternatively, the endeffector 12 may include a wire (not shown) that connects the remotesensor 368 the distal closure tube 42.

Typically, surgical instruments, such as the instrument 10, are cleanedand sterilized prior to use. In one sterilization technique, theinstrument 10 is placed in a closed and sealed container 280, such as aplastic or TYVEK container or bag, as shown in FIGS. 17 and 18. Thecontainer and the instrument are then placed in a field of radiationthat can penetrate the container, such as gamma radiation, x-rays, orhigh-energy electrons. The radiation kills bacteria on the instrument 10and in the container 280. The sterilized instrument 10 can then bestored in the sterile container 280. The sealed, sterile container 280keeps the instrument 10 sterile until it is opened in a medical facilityor some other use environment. Instead of radiation, other means ofsterilizing the instrument 10 may be used, such as ethylene oxide orsteam.

When radiation, such as gamma radiation, is used to sterilize theinstrument 10, components of the control unit 300, particularly thememory 308 and the processor 306, may be damaged and become unstable.Thus, according to various embodiments of the present invention, thecontrol unit 300 may be programmed after packaging and sterilization ofthe instrument 10.

As shown in FIG. 17, a remote programming device 320, which may be ahandheld device, may be brought into wireless communication with thecontrol unit 300. The remote programming device 320 may emit wirelesssignals that are received by the control unit 300 to program the controlunit 300 and to power the control unit 300 during the programmingoperation. That way, the battery 64 does not need to power the controlunit 300 during the programming operation. According to variousembodiments, the programming code downloaded to the control unit 300could be of relatively small size, such as 1 MB or less, so that acommunications protocol with a relatively low data transmission ratecould be used if desired. Also, the remote programming unit 320 could bebrought into close physical proximity with the surgical instrument 10 sothat a low power signal could be used.

Referring back to FIG. 19, the control unit 300 may comprise aninductive coil 402 to pick up wireless signals from a remote programmingdevice 320. A portion of the received signal may be used by a powercircuit 404 to power the control unit 300 when it is not being poweredby the battery 64.

Input signals received by the coil 402 acting as a receiving antenna maybe demodulated by a demodulator 410 and decoded by a decoder 412. Theinput signals may comprise programming instructions (e.g., code), whichmay be stored in a non-volatile memory portion of the memory 308. Theprocessor 306 may execute the code when the instrument 10 is inoperation. For example, the code may cause the processor 306 to outputcontrol signals to various sub-systems of the instrument 10, such as themotor 65, based on data received from the sensors 368.

The control unit 300 may also comprise a non-volatile memory unit 414that comprises boot sequence code for execution by the processor 306.When the control unit 300 receives enough power from the signals fromthe remote control unit 320 during the post-sterilization programmingoperation, the processor 306 may first execute the boot sequence code(“boot loader”) 414, which may load the processor 306 with an operatingsystem.

The control unit 300 may also send signals back to the remoteprogramming unit 320, such as acknowledgement and handshake signals, forexample. The control unit 300 may comprise an encoder 416 for encodingthe signals to then be sent to the programming device 320 and amodulator 418 for modulating the signals according to the modulationscheme. The coil 402 may act as the transmitting antenna. The controlunit 300 and the remote programming device 320 may communicate using anysuitable wireless communication protocol (e.g., Bluetooth) and anysuitable frequency (e.g., an ISM band). Also, the control unit 300 maytransmit signals at a different frequency range than the frequency rangeof the received signals from the remote programming unit 320.

FIG. 20 is a simplified diagram of the remote programming device 320according to various embodiments of the present invention. As shown inFIG. 20, the remote programming unit 320 may comprise a main controlboard 230 and a boosted antenna board 232. The main control board 230may comprise a controller 234, a power module 236, and a memory 238. Thememory 238 may stored the operating instructions for the controller 234as well as the programming instructions to be transmitted to the controlunit 300 of the surgical instrument 10. The power module 236 may providea stable DC voltage for the components of the remote programming device320 from an internal battery (not shown) or an external AC or DC powersource (not shown).

The boosted antenna board 232 may comprise a coupler circuit 240 that isin communication with the controller 234 via an I²C bus, for example.The coupler circuit 240 may communicate with the control unit 300 of thesurgical instrument via an antenna 244. The coupler circuit 240 mayhandle the modulating/demodulating and encoding/decoding operations fortransmissions with the control unit. According to other embodiments, theremote programming device 320 could have a discrete modulator,demodulator, encoder and decoder. As shown in FIG. 20, the boost antennaboard 232 may also comprise a transmitting power amp 246, a matchingcircuit 248 for the antenna 244, and a filter/amplifier 249 forreceiving signals.

According to other embodiments, as shown in FIG. 20, the remoteprogramming device could be in communication with a computer device 460,such as a PC or a laptop, via a USB and/or RS232 interface, for example.In such a configuration, a memory of the computing device 460 may storethe programming instructions to be transmitted to the control unit 300.In another embodiment, the computing device 460 could be configured witha wireless transmission system to transmit the programming instructionsto the control unit 300.

In addition, according to other embodiments, rather than using inductivecoupling between the control unit 300 and the remote programming device320, capacitively coupling could be used. In such an embodiment, thecontrol unit 300 could have a plate instead of a coil, as could theremote programming unit 320.

In another embodiment, rather than using a wireless communication linkbetween the control unit 300 and the remote programming device 320, theprogramming device 320 may be physically connected to the control unit300 while the instrument 10 is in its sterile container 280 in such away that the instrument 10 remains sterilized. FIG. 21 is a diagram of apackaged instrument 10 according to such an embodiment. As shown in FIG.22, the handle 6 of the instrument 10 may include an external connectioninterface 470. The container 280 may further comprise a connectioninterface 472 that mates with the external connection interface 470 ofthe instrument 10 when the instrument 10 is packaged in the container280. The programming device 320 may include an external connectioninterface (not shown) that may connect to the connection interface 472at the exterior of the container 280 to thereby provide a wiredconnection between the programming device 320 and the externalconnection interface 470 of the instrument 10.

The various embodiments of the present invention have been describedabove in connection with cutting-type surgical instruments. It should benoted, however, that in other embodiments, the inventive surgicalinstrument disclosed herein need not be a cutting-type surgicalinstrument, but rather could be used in any type of surgical instrumentincluding remote sensor transponders. For example, it could be anon-cutting endoscopic instrument, a grasper, a stapler, a clip applier,an access device, a drug/gene therapy delivery device, an energy deviceusing ultrasound, RF, laser, etc. In addition, the present invention maybe in laparoscopic instruments, for example. The present invention alsohas application in conventional endoscopic and open surgicalinstrumentation as well as robotic-assisted surgery.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Although the present invention has been described herein in connectionwith certain disclosed embodiments, many modifications and variations tothose embodiments may be implemented. For example, different types ofend effectors may be employed. Also, where materials are disclosed forcertain components, other materials may be used. The foregoingdescription and following claims are intended to cover all suchmodification and variations.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

1. A combination comprising: a surgical instrument comprising a controlunit; and a remote programming device for wirelessly programming thecontrol unit.
 2. The combination of claim 1, further comprising acontainer containing the surgical instrument, and wherein the remoteprogramming device is outside of the container.
 3. The combination ofclaim 2, wherein the control unit comprises: a power circuit forpassively powering the control unit from wireless signals received fromthe remote programming device; a memory for storing code received fromthe remote programming unit; and a processor for executing the codestored in the memory.
 4. The combination of claim 3, wherein the memoryfurther stores a boot loading sequence for execution by the processor.5. The combination of claim 1, wherein the control unit and the remoteprogramming device are inductively coupled.
 6. The combination of claim1, wherein the control unit and the remote programming device arecapacitively coupled.
 7. The combination of claim 2, wherein thesurgical instrument comprises: a handle housing the control unit; ashaft connected to the handle; and an end effector connected to theshaft.
 8. The combination of claim 7, wherein the end effector comprisesa cutting instrument.
 9. The combination of claim 8, wherein the housingfurther comprises: a motor in communication with the control unit; and abattery for powering the motor.
 10. A method comprising: packaging asurgical instrument in a container; sterilizing the surgical instrumentwhile the surgical instrument is in the container; and programming thesurgical instrument while the surgical instrument is in the containerwith a programming device positioned outside of the container.
 11. Themethod of claim 10, wherein programming the surgical instrumentcomprises wirelessly programming the surgical instrument with theprogramming device.
 12. The method of claim 10, wherein the step ofprogramming the surgical instrument is performed after the step ofsterilizing the surgical instrument.
 13. The method of claim 12, whereinthe step of sterilizing the surgical instrument comprises subjecting thesurgical instrument to radiation.
 14. The method of claim 13, whereinthe radiation comprises gamma radiation.
 15. The method of claim 12,wherein the step of sterilizing the surgical instrument comprisessubjecting the surgical instrument to ethylene oxide.
 16. The method ofclaim 10, wherein the surgical instrument comprises a programmablecontrol unit.
 17. The method of claim 10, wherein: the surgicalinstrument comprises an external connection interface; the containercomprises a connection interface that mates with the external connectioninterface when the surgical instrument is contained in the container;and programming the instrument comprises connecting the programmingdevice to the connection interface of the container.
 18. A combinationcomprising: a surgical instrument comprising a handle, wherein thehandle comprises: a control unit in the handle; and an externalconnection interface for the control unit; and a container containingthe surgical instrument, wherein the container comprises a connectioninterface that comprises an interior end that mates with the externalconnection interface of the surgical instrument and an exterior end atthe exterior of the container.
 19. The combination of claim 18, furthercomprising a programming device adapted for connection to the exteriorend of the connection interface of the container.
 20. A surgicalinstrument comprising a wirelessly programmable control unit.
 21. Thesurgical instrument of claim 20, wherein the wirelessly programmablecontrol unit includes an antenna for receiving programming code from aremote, wireless programming device.
 22. The surgical instrument ofclaim 20, further comprising: a motor in communication with the controlunit; and a battery for powering the motor.
 23. The surgical instrumentof claim 22, further comprising an end effector, wherein the endeffector comprises a sensor, and wherein the sensor is in communicationwith the wirelessly programmable control unit.
 24. The surgicalinstrument of claim 20, wherein the control unit comprises: a powercircuit for passively powering the control unit from wireless signalsreceived from a remote programming device; a memory for storing codereceived from the remote programming unit; and a processor for executingthe code stored in the memory.
 25. The combination of claim 24, whereinthe memory further stores a boot loading sequence for execution by theprocessor.
 26. The combination of claim 20, wherein the surgicalinstrument comprises an endoscopic surgical instrument.
 27. Thecombination of claim 23, wherein the end effector further comprises acutting instrument.